Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Natural Daylight to Improve 24h Metabolism and Glucose Control in Type 2 Diabetes
Verified date | August 2023 |
Source | Maastricht University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will investigate the potential benefit of scheduled natural daylight exposure to improve glucose control in type 2 diabetes (T2D) patients and to unravel molecular mechanisms underlying the effects of natural daylight on circadian clocks and (glucose) metabolism in human skeletal muscle from T2D patients. Participants will stay at our research facilities and will be exposed to natural daylight or artificial light during the daytime over 4.5 days in a randomized cross-over design. For both conditions, the evening and night will be spent under standardized dim and dark conditions.
Status | Completed |
Enrollment | 13 |
Est. completion date | April 18, 2023 |
Est. primary completion date | November 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility | Inclusion Criteria: - Participants are able to provide signed and dates written consent prior to any study specific procedures - Male + females (postmenopausal defined as at least 1 year post cessation of menses) - T2DM duration at least 1 year - BMI: = 25 kg/m² - Age: 40-75 - Well-controlled diabetes with respect to glycemic control and on stable anti-diabetes medication regimes - Habitual bedtime of 23:00 ± 2h - Regular sleep duration (7-9 h/night) - Stable dietary habits: no weight gain or loss > 5 kg in the last three months Exclusion Criteria: - Insulin treatment - Uncontrolled hypertension - Signs of active diabetes-related co-morbidities like active cardiovascular diseases, active diabetic foot, polyneuropathy or retinopathy - Signs of active liver or kidney malfunction - Use of SGLT2 inhibitors - Using > 400mg caffeine daily (more than 4 coffee or energy drink) - Extreme early bird or extreme night person (score =30 or =70 on MEQ-SA questionnaire) - shift work or travel across more than one time zone in the 3 months before the study - Heavily varying sleep-wake rhythm - Frequent engagement in programmed exercise as judged by the investigator - Any medication that will interfere with the study outcomes or hamper the safety of the participant - Alcohol consumption of >2 servings per day for men and >1 serving per day for woman - Significant food allergies/intolerance (seriously hampering study meals) - Subjects who do not want to be informed about unexpected medical findings during the screening /study, or do not wish that their physician is informed - Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the Investigator - Smoking in the past 6 months |
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastricht University | Maastricht |
Lead Sponsor | Collaborator |
---|---|
Maastricht University | University of Geneva, Switzerland, Velux Fonden |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 24 hour energy expenditure | Energy expenditure (kJ/min) | measured at 8:00, 13:00, 18:00 and 22:30 on Day 4 | |
Other | 24h whole-body energy metabolism (cabrohydrate oxidation) | Carbohydrate oxidation (µmol/kg x min) measured by indirect calorimetry | measured at 8:00, 13:00, 18:00 and 22:30 on Day 4 | |
Other | 24h whole-body energy metabolism (fatty acid oxidation) | Fatty acid oxidation (µmol/kg x min) measured by indirect calorimetry | measured at 8:00, 13:00, 18:00 and 22:30 on Day 4 | |
Other | 24h profiles of plasma metabolites (i.e. free fatty acids, triglycerides, insulin) | Plasma levels determined from venous blood draws | measured on Day 4 at 8:00, 10:00, 12:00, 13:00, 14:00, 16:00, 18:00, 20:00, 22:00, 23:00, and on Day 5 at 00:00, 02:00, 04:00 and 06:00h | |
Other | Mass spectrometry-based 24h serum lipidomics | analysis of all lipid species evident in serum | measured on Day 4 at 8:00, 12:00, 16:00, 20:00, and on Day 5 at 00:00, 04:00 and 8:00 | |
Other | Sleep quality questionnaire (Leeds Sleep Evaluations Questionnaire - LSEQ) | LSEQ scores | after each of the 4 nights | |
Other | Sleep quality questionnaire (Pittsburgh Sleep Quality Index - PSQI) | PSQI scores | after each of the 4 nights | |
Other | 24h blood pressure | blood pressure (mmHg) | measured hourly from 7:00 to 23:00h on Day 4, and every second hour from 0:00 to 6:00 on Day 5 | |
Other | 24h heart rate | heart rate (bpm) assesses through chest-worn heart rate monitor | measured continously over 4.5 days | |
Other | 24h skin temperature | skin temperature (°C) assessed via wireless temperature sensors (iButtons) | measured continously on Day 3 | |
Other | 24h core body temperature | Core body temperature measured by an ingested telemetric pill (°C) | measured continously on Day 3 | |
Other | mRNA in peripheral blood mononuclear cells (PBMC) of markers involved in the molecular clock | Quantify mRNA levels by micro array | blood samples taken on Day 4 at 8:00, 13:00, 18:00, 23:00, and on Day 5 at 4:00 and 9:00 | |
Primary | average 24h blood glucose levels | Interstistial glucose levels determined by continuous glucose monitoring | continously over 4.5 days | |
Secondary | Postprandial metabolism upon a mixed-meal tolerance test (energy expenditure) | Energy expenditure (kJ/min) measured by indirect calorimetry | measured at 9:00, 9:30, 10:00, 11:00, 12:00 and 13:00 on Day 5 | |
Secondary | Postprandial metabolism upon a mixed-meal tolerance test (carbohydrate oxidation) | Carbohydrate oxidation (µmol/kg x min) measured by indirect calorimetry | measured at 9:00, 9:30, 10:00, 11:00, 12:00 and 13:00 on Day 5 | |
Secondary | Postprandial metabolism upon a mixed-meal tolerance test (fatty acid oxidation) | Fatty acid oxidation (µmol/kg x min) measured by indirect calorimetry | measured at 9:00, 9:30, 10:00, 11:00, 12:00 and 13:00 on Day 5 | |
Secondary | Postprandial plasma metabolites upon a mixed-meal tolerance test (glucose) | Plasma glucose levels determined from venous blood draws | measured at 9:00, 9:15, 9:30, 9:45, 10:00, 10:30, 11:00, 11:30, 12:00, 13:00 on Day 5 | |
Secondary | Postprandial plasma metabolites upon a mixed-meal tolerance test (insulin) | Plasma insulin levels determined from venous blood draws | measured at 9:00, 9:15, 9:30, 9:45, 10:00, 10:30, 11:00, 11:30, 12:00, 13:00 on Day 5 | |
Secondary | Postprandial plasma metabolites upon a mixed-meal tolerance test (free fatty acids) | Plasma FFA levels determined from venous blood draws | measured at 9:00, 9:15, 9:30, 9:45, 10:00, 10:30, 11:00, 11:30, 12:00, 13:00 on Day 5 | |
Secondary | Postprandial plasma metabolites upon a mixed-meal tolerance test (triglycerides) | Plasma triglyceride levels determined from venous blood draws | measured at 9:00, 9:15, 9:30, 9:45, 10:00, 10:30, 11:00, 11:30, 12:00, 13:00 on Day 5 | |
Secondary | Skeletal muscle biopsy outcomes (Circadian transciptome) | Quantify DNA by micro-array | muscle tissue taken at 7:30h on Day 5 | |
Secondary | Culturing human primary myotubes to assess circadian reporter characteristics | in vivo culturing of primary myotubes | muscle tissue taken at 7:30h on Day 5 |
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